FDA March 27 approved Imfinzi (durvalumab) in combination with etoposide and either carboplatin or cisplatin as first-line treatment of patients with extensive-stage small cell lung cancer.
AstraZeneca sponsors Imfinzi.
Efficacy of this combination in patients with previously untreated ES-SCLC was investigated in CASPIAN, a randomized, multicenter, active-controlled, open-label, trial (NCT03043872). The evaluation was based on the comparison of patients randomized to Imfinzi plus chemotherapy vs. chemotherapy alone. The major efficacy outcome measure was overall survival. Additional efficacy outcome measures were investigator-assessed progression-free survival and objective response rate, per RECIST v1.1.
Median OS was 13.0 months (95% CI: 11.5, 14.8) in the Imfinzi plus chemotherapy arm compared with 10.3 months (95% CI: 9.3, 11.2) in the chemotherapy alone arm (hazard ratio 0.73; 95% CI: 0.59, 0.91; p=0.0047).
Investigator-assessed PFS (96% of total planned events) showed a HR of 0.78 (95% CI: 0.65, 0.94), with median PFS of 5.1 months (95% CI: 4.7, 6.2) in the Imfinzi plus chemotherapy arm and 5.4 months (95% CI: 4.8, 6.2) in the chemotherapy alone arm. The investigator-assessed confirmed ORR was 68% (95% CI: 62%, 73%) in the Imfinzi plus chemotherapy arm and 58% (95% CI: 52%, 63%) in the chemotherapy alone arm.
